Transcept announces PDUFA action date for Intermezzo

POINT RICHMOND, Calif. — Transcept announced Monday that the Food and Drug Administration has classified the drug maker’s insomnia treatment as a complete class-2 response, and assigned the drug a Prescription Drug User Fee Act action date for this summer.

Transcept resubmitted its new drug application for Intermezzo (zolpidem tartrate) on Jan. 18 after receiving a complete response letter from the FDA in October 2009. The drug maker said for the completion of the NDA review, the FDA set the PDUFA action date for July 14.

Intermezzo is a pill placed under the tongue for treating patients who awake in the middle of the night and have difficulty falling asleep again.

NACDS files legal brief in case concerning military Tricare program

ALEXANDRIA, Va. — Concerns that contracting rules affecting healthcare providers that service Tricare beneficiaries could extend to retail pharmacies has prompted the country’s largest chain pharmacy lobby to file a friend-of-the-court brief in a lawsuit over the regulations.

The National Association of Chain Drug Stores filed an amicus curiae brief in support of the defendant in the case, Office of Federal Contract Compliance Programs, U.S. Department of Labor v. Florida Hospital of Orlando.

The hospital is appealing a decision by a DoL administrative law judge’s decision that would extend regulations and requirements to some providers that service Tricare beneficiaries, including new record-keeping and employment requirements.

“At a time when the administration and Congress agree that federal rules and regulations need to be seriously reviewed and revised, the DoL’s decision to expand new contractual requirements to Tricare providers seems misguided and misplaced,” NACDS president and CEO Steve Anderson said.

The NACDS filed the brief over concerns that the judge’s decision could create a precedent whereby Tricare-providing pharmacies could be subject to the regulations, even though pharmacies have no contractual obligations to the federal government, and that the regulations could force the pharmacies out of the Tricare system.

RARITAN, N.J. — A drug made by Johnson & Johnson may be effective in reducing pain in patients with a complication of diabetes, according to a late-stage clinical study.

The phase-3 study, published in the January issue of the journal Current Medical Research and Opinion, found that extended-release tapentadol was more effective than placebo in relieving moderate to severe chronic pain in patients with diabetic peripheral neuropathy. J&J markets an immediate-release formulation of the drug under the brand name Nucynta, which the Food and Drug Administration approved in November 2008.

“What’s encouraging is that at the beginning of this study, the average pain rating across the entire group of patients was severe, but after three weeks on tapentadol ER, the average pain score dropped substantially to a range considered to be mild pain,” therapeutic leader for pain at J&J subsidiary Ortho-McNeil-Janssen Scientific Affairs Bruce Moskovitz said. “After double-blind randomization, the group of patients that stayed on tapentadol ER maintained its pain reduction, while the group that switched to placebo experienced a significant increase in its average pain score.”

RELATED NEWS

The Food and Drug Administration has approved a generic of Hoffman-La Roche’s Tamiflu (oseltamivir phosphate) capsules from Lupin. The company’s generic will be available in 30-, 45- and 75-mg dosage strengths.
The product is inficated to treat acute, uncomplicated influenza A and B in patients 2 weeks of age and older, as well as to prevent influenza A and B in patients 1 year old and older. The drug had U.S. sales of roughly $467.8 million for the 12 months ended October 2017, according to IQVIA data.

Behavioral health pharmacy and telepsychiatry company Genoa, a QoL Healthcare Company, has reached a big number with its remote psychiatry offering. The Tukwila, Wash.-based company announced Tuesday that it had facilitated more than 100,000 telepsych consultations on its video conferencing platform.
Genoa attributes the milestone to its recent buildup of its telepsychiatry operations, which grew to include 35 in 2017 from 20 at the start of the year, and included 250 providers. In 2017, the company grew to serve more than 2,500 patients per week.

This year's flu continues to be Texas big, according to the Walgreens Flu Index released Wednesday, as the top 10 communities experiencing the greatest amount of flu incidence were all located in the Lone Star State for the week ended Jan. 6.
Iowa, Idaho and Arkansas rank behind Texas in terms of flu activity. And Montana, Idaho and Iowa ranked highest among states experiencing flu activity gains.

Amneal Biosciences has launched its generic of Otsuka’s Busulfex (busulfan injection, 6 mg/ml). The product is indicated to treat chronic myelogenous leukemia.
Amneal said that its generic is available in cartons of eight single-dose vials, each of which contains 60 mg of the drug in a 10-ml clear sterile solution. The product is made without natural rubber, latex, gluten or preservatives, Amneal said.
The drug had U.S. sales of roughly $80 million for the 12 months ended October 2017, according to data from IQVIA.

Amneal Pharmaceuticals has launched sevelamer carbonate tablets, 800 mg, in 270-count bottles. This generic from the Bridgewater, N.J.-based company is an AB-rated therapeutic equivalent to Renvela.
Amneal also launched five other products in addition to sevelamer carbonate:

Forgotten Password

Registration complete

REGISTER

USERNAME *

Spaces are allowed; punctuation is not allowed except for periods, hyphens, and underscores.

E-MAIL ADDRESS *

A valid e-mail address. All e-mails from the system will be sent to this address. The e-mail address is not made public and will only be used if you wish to receive a new password or wish to receive certain news or notifications by e-mail.

Password *

Confirm Password *

Please choose a password for your account; it must be 8 - 30 characters. .

First Name *

Last Name *

Company Name *

Job Title *

ZIP *

Are you a *

Retailer or Healthcare professional

Non-Retailer

How many stores do you operate?: *

Which best describes the business/industry you work in?: *

Which best describes your job title?: *

Please select the newsletters you would like to subscribe to

DSN A.M.
Daily news stories covering the retail drug industry

Breaking News
First-to-the-market with developing stories in the industry